Helfrich Y R, Kang S, Hamilton T A, Voorhees J J
Department of Dermatology, University of Michigan, Ann Arbor, MI 48109-0314, USA.
Br J Dermatol. 2007 Aug;157(2):369-74. doi: 10.1111/j.1365-2133.2007.08037.x. Epub 2007 Jun 26.
Becocalcidiol is a vitamin D(3) analogue which has not caused hypercalcaemia or significant irritation in preclinical trials.
To evaluate the efficacy and safety of two dosing regimens of becocalcidiol ointment (low dose = 75 microg g(-1) once daily for 8 weeks; high dose = 75 microg g(-1) twice daily for 8 weeks) in the treatment of plaque-type psoriasis.
One hundred and eighty-five subjects with chronic plaque-type psoriasis affecting 2-10% of their body surface area took part in a multicentre, double-blind, parallel-group, vehicle-controlled, randomized controlled trial comparing topical application of placebo, becocalcidiol 75 microg g(-1) once daily (low dose) or becocalcidiol twice daily (high dose) for 8 weeks. Main outcomes included Physician's Static Global Assessment of Overall Lesion Severity (PGA) score; Psoriasis Symptom Severity (PSS) score; adverse events; and laboratory assessment.
In the intent-to-treat population at week 8, high-dose becocalcidiol was statistically superior to vehicle [P = 0.002; 95% confidence interval (CI) 6.7-32.2], with 16 of 61 (26%) subjects achieving a PGA score of clear or almost clear. Greater improvement in PSS score was seen with high-dose becocalcidiol than with vehicle, but this result did not quite achieve statistical significance (P = 0.052; 95% CI -16.2 to 0.1). In all groups, therapy was safe and well tolerated, with fewer subjects experiencing irritation than is reported in studies using calcipotriol.
Treatment with high-dose topical becocalcidiol for 8 weeks led to almost or complete clearing of moderate plaque-type psoriasis in over a quarter of patients. Therapy was safe and well tolerated.
贝可骨化二醇是一种维生素D(3)类似物，在临床前试验中未引起高钙血症或明显刺激。
评估两种剂量方案的贝可骨化二醇软膏（低剂量=75μg/g，每日一次，共8周；高剂量=75μg/g，每日两次，共8周）治疗斑块型银屑病的疗效和安全性。
185例慢性斑块型银屑病患者，其体表面积受累2%-10%，参加了一项多中心、双盲、平行组、赋形剂对照、随机对照试验，比较局部应用安慰剂、每日一次75μg/g的贝可骨化二醇（低剂量）或每日两次的贝可骨化二醇（高剂量），持续8周。主要结局包括医生对整体皮损严重程度的静态整体评估（PGA）评分；银屑病症状严重程度（PSS）评分；不良事件；以及实验室评估。
在意向性治疗人群中，第8周时，高剂量贝可骨化二醇在统计学上优于赋形剂[P=0.002；95%置信区间（CI）6.7-32.2]，61例患者中有16例（26%）的PGA评分为清除或几乎清除。高剂量贝可骨化二醇组的PSS评分改善程度大于赋形剂组，但该结果未达到统计学显著性（P=0.052；95%CI -16.2至0.1）。在所有组中，治疗安全且耐受性良好，与使用卡泊三醇的研究相比，出现刺激的患者较少。
高剂量局部应用贝可骨化二醇治疗8周可使超过四分之一的中度斑块型银屑病患者几乎或完全清除。治疗安全且耐受性良好。
